510(k) Report

FDA applicant

Atraverse Medical

Cardiff By The Sea, CA4 decisions2024–20260 recalls

FDA records 4 decisions for Atraverse Medical (Cardiff By The Sea, CA) from 2024 to 2026: 4 510(k) clearances. Most are in product codes DXF (Catheter, Septostomy) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Atraverse Medical, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Atraverse Medical’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2024: 12025: 22026 (partial year): 1
2024high 2 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Atraverse Medical by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Atraverse Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXFCatheter, Septostomy3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K240900HOTWIRE™ RF GuidewireAtraverse Medical · 20241cites it
  • K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 20251cites it

What has FDA decided for it lately?

  • K260292Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical · 2026
  • K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 2025
  • K252083HOTWIRE™ System RF Generator and Footswitch (optional accessory)Atraverse Medical, Inc. · 2025
  • K240900HOTWIRE™ RF GuidewireAtraverse Medical · 2024

All 2 as Atraverse Medical →All 2 as Atraverse Medical, Inc. →